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Strategic Orthopaedic-related 510(k) Update

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space. For certain companies, this represents a first clearance of an orthopaedic-related product. These are denoted with an asterisk.

Benvenue Medical
Kiva VCF Treatment System, K132817
  • PEEK Optima-based implant indicated for reduction and treatment of spinal fractures in thoracic and lumbar spine
  • “First new approach to the treatment of vertebral compression fractures in over a decade”

Edge Orthopaedics
Bite Compression Screw, K132893*
  • Sterile titanium self- drilling/self-tapping screws + corresponding instrumentation
  • Not for use in spine

Integrity Spine
Spine Core Intervertebral Fusion Device, K132718*
  • PEEK-based cervical interbody fusion system of parallel and lordotic cages in two footprints, contain tantalum markers
  • May be implanted as single device via anterior approach
  • Company’s products include Biologics (allograft, DBM, synthetic bone), PEEK, Metal (screws, plates, rods, taps), Stem Cells
     and PRP

Lanterna Medical Technologies
Santis Pedicle Screw, K133063*
  • For posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft
  • Can be implanted via open procedure or percutaneous MIS approach, or combination of both
  • Components are titanium-based alloy, or cobalt chrome
  • Swiss-based company marketing generic spinal implants

Mikron Makina
Spinal Fixation System, Polyaxial Pedicle Screws, Set Screws, Longitudinal Rods, K130073*
  • Titanium alloy top-loading multiple component posterior spinal fixation system

MTP Solutions
Titanium Suture Anchor, K133229*
  • For suture or tissue fixation in the foot. ankle, knee, hip, hand, wrist, elbow and shoulder

Toby Orthopedics
Wolf Lone Bone Plate System, K131834
  • Titanium alloy plates and fasteners used for repair of fractures, osteotomies and non-unions of upper extremity diaphysis
  • Supports use of staggered screw fixation mounted non-perpendicular to the plate, two divergent screws per hole or peg
     rather than a screw

Virak Orthopedic Research
Digifix External Fixation System, K132731*
  • For treatment of complex fracture/dislocations or fracture/subluxation, unstable dislocations and pilon fractures of
     the interphalangeal joint and post-traumatic joint contracture of the proximal interphalangeal joint

Source: FDA 510(k) Releasable Database, 11/13-1/14; news releases, company websites, etc.


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